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US4991629A - Gas-tight closure device for the connecting ends of tubes for biomedical fluid-transporting apparatus, particularly haemodialysis lines, which are sterilized by means of sterilizing gas - Google Patents

Gas-tight closure device for the connecting ends of tubes for biomedical fluid-transporting apparatus, particularly haemodialysis lines, which are sterilized by means of sterilizing gas Download PDF

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Publication number
US4991629A
US4991629A US07/248,016 US24801688A US4991629A US 4991629 A US4991629 A US 4991629A US 24801688 A US24801688 A US 24801688A US 4991629 A US4991629 A US 4991629A
Authority
US
United States
Prior art keywords
connector
cap
gas
tight closure
tubes
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Fee Related
Application number
US07/248,016
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English (en)
Inventor
Guala Ernesto
Beolchi Mario
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Industrie Borla SpA
Original Assignee
Industrie Borla SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from IT5367287U external-priority patent/IT212213Z2/it
Priority claimed from IT5379087U external-priority patent/IT212539Z2/it
Application filed by Industrie Borla SpA filed Critical Industrie Borla SpA
Assigned to INDUSTRIE BORLA S.P.A., AN ITALIAN JOINT STOCK CO. reassignment INDUSTRIE BORLA S.P.A., AN ITALIAN JOINT STOCK CO. ASSIGNMENT OF ASSIGNORS INTEREST. Assignors: BEOLCHI, MARIO, GUALA, ERNESTO
Application granted granted Critical
Publication of US4991629A publication Critical patent/US4991629A/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/20—Closure caps or plugs for connectors or open ends of tubes
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S285/00—Pipe joints or couplings
    • Y10S285/901—Cap closures
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S604/00—Surgery
    • Y10S604/905—Aseptic connectors or couplings, e.g. frangible, piercable

Definitions

  • the present invention relates in general to biomedical fluid-transporting apparatus, particularly but not exclusively haemodialysis lines, including tubes which are sterilised by means of sterilising gas, normally ethylene oxide.
  • the connecting ends of the tubes are provided with gas-tight closure devices.
  • the invention is particularly concerned with these gas-tight closure devices, which normally comprise a tubular connector having an internal Luer cone and provided with external screw-engagement projections, a cap which is fitted to the tubular connector, and hermetic sealing means between the cap and the tubular connector.
  • the hermetic sealing means comprise (as will be described in greater detail below with reference to FIG. 6) an internal axial appendage of the cap, which has an outer conical surface complementary to that of the Luer cone of the connector and is adapted to be a force fit within the latter in the fitted condition of the cap.
  • this solution has the disadvantage that it prevents the gas introduced into the tube from sterilising that portion of the surface of the Luer cone against which the appendage of the body bears.
  • the object of the present invention is to avoid the above problem and to produce a gas-tight closure device of the type defined at the beginning, by means of which it is possible to achieve and maintain complete sterilisation of the tube to which it is applied.
  • this object is achieved by virtue of the fact that the hermetic sealing means between the cap and the tubular connector are arranged outside the Luer cone of the connector and include complementary conical surfaces for the mutual force-coupling of the outer lateral wall of the connector and the inner wall of the cap.
  • the entire internal surface of the connector is effectively sterilised when the sterilising gas is introduced into the tube, whilst the closure effected by the cap remains hermetic.
  • the mutual coupling parts are normally constituted by complementary conical surfaces of the connector and the cap.
  • the conical surface of the connector may be situated upstream or downstream of the screw projections. with respect to the direction of fitting of the cap.
  • the cap may be internally threaded so that it can be screwed onto the screw projections of the connector, or may lack internal threading.
  • the hermetic sealing means also include an inner annular projection of the cap which is adapted to be placed in frontal sealing contact against the end of the connector, around the mouth of the Luer cone.
  • FIG. 1 is a schematic axial sectional view of a gas-tight closure device according to a first embodiment of the invention
  • FIGS. 2, 3, 4 and 5 show four possible variants of the device of FIG. 1, and
  • FIG. 6 is a view similar to FIG. 1 of a gas-tight closure device according to the prior art.
  • a gas-tight closure device for the connecting ends of tubes for biomedical fluid-transporting apparatus, for example, haemodialysis lines, which are sterilised by means of ethylene oxide or similar sterilisation gases, is generally indicated 1.
  • the connecting end is constituted by a tubular connector 2 of moulded plastics material having, at one, a tubular appendage 3 which is slightly tapered and is force-fitted into the end of a flexible tube 4.
  • a closure cap 7 is provided and is fitted to the outside of the connector 2 in the region of the Luer cone 6.
  • the known cap 7 has internal threading 9 which is screwed onto corresponding external screw-engagement projections 8 of the connector 2, and an inner axial appendage 13 whose conical shape is complementary to that of the Luer cone 6.
  • the inner appendage 10 of the cap 7 is force-fitted into the Luer cone 6, so as to effect the gas-tight closure thereof and thus enable the sterilisation gas to be introduced into the tube 4 and retained therein.
  • the region of the outer surface of the Luer cone 6 against which the outer surface of the appendage 10 of the cap 7 bears cannot be reached by the sterilisation gas and cannot consequently be sterilised, with the risks which ensue.
  • FIGS. 1 to 5 in which parts identical or similar to those described with reference to FIG. 6 are indicated by the same reference numerals.
  • the hermetic sealing of the connector 2 by the cap 7 is effected outside the Luer cone 6, and in the case of FIGS. 1 to 4 solely by means of parts for the mutual force-coupling of the outer wall of the connector 2 and the inner wall of the cap 7.
  • these mutual force-coupling parts are constituted by an outer conical surface 10 of the connector 2, interposed between the flange 5 and the screw projections 8, and a corresponding inner conical surface 11 extending from the end edge of the cap 7.
  • the entire surface of the Luer cone 6 may be sterilised effectively by the sterilisation gas introduced into the tube 4 and the escape of the sterilisation gas is effectively prevented by the lateral seal constituted by the complementary surfaces 10 and 11.
  • FIGS. 2 to 4 show three possible variants of the hermetic sealing system between the connector 2 and the cap 7, which fall within the scope of the concept consisting of the provision of parts solely for the lateral sealing of the two elements.
  • elements identical or similar to those already described with reference to FIG. 1 are indicated by the same reference numerals.
  • FIG. 2 differs from that described above only in that the outer conical surface 10 of the connector 2 is formed near the mouth of the Luer cone 6, that is, upstream of the screw-engagement projections 8 with respect to the direction of fitting of the cap 7.
  • the conical surface of the latter is formed correspondingly near the end of the cap 7.
  • the coupling surfaces 10 and 11 are positioned as in the case of FIG. 1: however, in this variant also, the cap lacks internal threading and is retained as in the case of FIG. 1: however, in this variant also, the cap lacks internal threading and is retained by the force-coupling between the surfaces 10 and 11, as in the case of FIG. 3.
  • the hermetic sealing of the connector 2 by the cap 7 is effected, again externally of the Luer cone 6, both frontally and laterally against the outer surface of the connector 2 in the region of the cone 6.
  • the frontal seal is effected by means of an inner annular projection 12 of the cap 7 which, when the latter is screwed onto the connector 2, bears against the end of the connector 2, around the mouth 6a of the cone 6.
  • the lateral sealing is effected by means of an external enlargement 10 of the connector 2, which is spaced axially from the screw-engagement projections 9 and against the slightly conical outer surface of which the complementary conical surface of the end part 11 of the inner wall of the cap 7 is force-fitted in the screwed-on condition.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)
US07/248,016 1987-09-25 1988-09-23 Gas-tight closure device for the connecting ends of tubes for biomedical fluid-transporting apparatus, particularly haemodialysis lines, which are sterilized by means of sterilizing gas Expired - Fee Related US4991629A (en)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IT53672/87[U] 1987-09-25
IT5367287U IT212213Z2 (it) 1987-09-25 1987-09-25 Dispositivo di chiusura stagna per terminali di connessione di tubazioni sterilizzate mediante gas di sterilizzazione per apparecchiature biomedicali di trasporto di fluido particolarmente linee per emodialisi
IT53790/87[U] 1987-11-04
IT5379087U IT212539Z2 (it) 1987-11-04 1987-11-04 Dispositivo di chiusura stagna per terminali di connessione di tubazioni sterilizzate mediante gas di ste rilizzazione per apparecchiature biomedicali di trasporto di fluido particolarmente linee per emodialisi

Publications (1)

Publication Number Publication Date
US4991629A true US4991629A (en) 1991-02-12

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Family Applications (1)

Application Number Title Priority Date Filing Date
US07/248,016 Expired - Fee Related US4991629A (en) 1987-09-25 1988-09-23 Gas-tight closure device for the connecting ends of tubes for biomedical fluid-transporting apparatus, particularly haemodialysis lines, which are sterilized by means of sterilizing gas

Country Status (3)

Country Link
US (1) US4991629A (de)
EP (1) EP0309426A3 (de)
DE (1) DE8817024U1 (de)

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DE8817024U1 (de) 1991-12-12
EP0309426A3 (de) 1991-04-03
EP0309426A2 (de) 1989-03-29

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